.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP

.018 HI-TORQUE FLOPPY GUIDE WIRE W/ PRESHAPED TIP is an FDA 510(k)-cleared medical device (K902755) manufactured by Advanced Cardiovascular Systems, Inc.. This device is classified under the Cardiovascular specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 3, 1990. Regulation: 8.